Newborn circumcision is the most commonly performed surgical procedure in the United States with over 1 million circumcisions performed annually. Circumcisions have been performed for centuries for both religious and medical reasons. Various instruments have been developed to help facilitate removal of the foreskin from the penis. These instruments were intended to provide some level of hemostasis to help control bleeding, to provide a uniform cutting surface, and to protect the underlying glans penis from trauma associated with the procedure. Of these devices, three are commonly used for neonatal circumcision in the United States: U.S. Pat. No. 119,180 ('180) by A. A. Goldstein, U.S. Pat. No. 2,747,576 ('576) by H. Bronstein, and U.S. Pat. No. 2,272,072 ('072) by C J. Ross and U.S. Pat. No. 3,056,407 ('407) by D. H. Kariher et al.
One shortcoming of all the prior art is that a dorsal slit in the foreskin is required. In a neonate, the opening of the foreskin at the tip of the penis is small and tight. A dorsal slit is made to free adhesions or separate the foreskin from the penis, allow enough room to accommodate a cutting surface, and to facilitate alignment of a cutting tool. This procedure causes a traumatic incision to be made on the dorsal surface of the foreskin, perpendicular to and unrelated to the final incision. In order to create the dorsal slit, considerable trauma is exerted to the foreskin and to the neonate.
In order to initiate the dorsal slit, it is necessary to grasp the foreskin. In practice, this is routinely done with two hemostats that are used to clamp and crush the distal foreskin at the ten o'clock position and the two o'clock position. By clamping and therefore crushing the foreskin, the surgeon is able to apply counter traction with one hand holding both instruments, while the surgeon uses the free hand to manipulate a third, straight hemostat to probe under the foreskin and then crush along the dorsal aspect. Scissors are used to cut the dorsal slit where the tissue was crushed. In order to create the dorsal slit, the foreskin of the newborn infant is unnecessarily crushed multiple times and cut.
Studies published by the American Academy of Pediatrics state that a majority of circumcisions are done without any form of anesthesia. The dorsal slit incision accounts for a significant amount of the pain and trauma associated with a circumcision. In addition, the dorsal slit can be a source for significant bleeding and possible infection. Additionally, the Food and Drug Administration (FDA) regularly reports cases where when attempting to perform the dorsal slit the surgeon inadvertently inserts the tip of the scissors into the urethral meatus and cuts not only through the foreskin but the glans penis itself.
The most commonly used neonatal circumcision clamp is described in U.S. Pat. No. 119,180 ('180) by A. A. Goldstein (referred to herein as the Gomco). It consists of a metallic bell that is used to cover the glans or head of the penis to provide protection. After the dorsal slit is made as described above, the foreskin is pulled over the bell and the bell is advanced upward through a hole that serves as a clamping surface. A fulcrum and a screw nut are used to apply a force between the clamp and the bell, which crushes the foreskin and serves to help control bleeding during the incision. One of the shortcomings of the Gomco is the difficulty to pull the foreskin up through the clamp because of the small hole and the size of the clamp. It is a common practice for surgeons using the Gomco to use a common safety pin to pierce the foreskin of the penis on either side of the dorsal slit to hold the foreskin together and to facilitate pulling the foreskin into the clamp. Piercing the foreskin twice with a sharp, large needle generates unnecessary pain and increases the possibility of bleeding and traumatic complications. Yet another shortcoming of the Gomco is that the bell is separate from the clamp making it possible to use the wrong size bell with the wrong size clamp. Traumatic complications, including penile amputations, have been caused because of this mismatch of bell and clamp. Furthermore, it is awkward to manipulate the large clamp and to attempt to pull the foreskin through the small bell opening while engaging the clamping mechanism. Lastly, the final incision is made with the free hand of the surgeon with a conventional scalpel attempting to cut around the bell. This procedure imposes a possibility of inadvertent placement of the scalpel in the wrong position with associated catastrophic outcomes, such as penile amputation.
Another commonly used circumcision device is described in U.S. Pat. No. 2,272,072 by Ross and U.S. Pat. No. 3,056,407 by Kariher et al. (referred to herein as the Plastibell), which also requires the traumatic dorsal slit. The Plastibell employs a plastic bell that is tied off with a string in a form of tourniquet. The remaining foreskin is trimmed with scissors. The plastic handle of the bell is broken off and the plastic bell stays in place until the foreskin necrosis and falls off The most reported complication of the Plastibell is increased infections due to the foreign body nature of the plastic bell, string, and necrotic tissue. Many parents object to this method, because they do not want to have to worry about the plastic bell that stays in place for up to 5 days following the circumcision. Another shortcoming is that the string can be cut inadvertently by the surgeon performing the circumcision causing excessive bleeding. The string can also be tied with insufficient applied pressure to prevent bleeding. As with the Gomco, the chance for damage to the urethral opening of the glans is possible because the surgeon makes the incision with scissors. Lastly, it is very difficult and awkward to simultaneously hold the plastic bell in place, keep the foreskin together, and tie a knot in the string at the precise location on the plastic bell.
Yet another circumcision device is described in U.S. Pat. No. 2,747,576 ('576) by H. Bronstein (referred to herein as the Mogen clamp). The Mogan clamp is used less frequently because it is difficult to ensure that excessive foreskin or the head of the penis has not been inadvertently pulled up into the clamp. If the head of the penis is inadvertently pulled up into the clamp, the resulting clamping and incision causes an amputation of the tip of the penis. The FDA has issued several warnings regarding this shortcoming of the Mogen clamp. Furthermore, the cosmetic outcome is often that the remaining foreskin is lopsided and asymmetric because the incision is made in a linear direction and the underlying tissue has a circumferential orientation.
In August of 2000, the FDA released a cautionary statement regarding the Gomco and Mogen type clamps. The FDA reported receiving 105 reports of injuries involving circumcision clamps between the months of July 1996 and January 2000 or approximately 30 injuries per year. Assuming a similar injury rate for the preceding 54 years, when these devices were initially introduced, they have likely accounted for well over 1600 traumatic outcomes. Those incidents reported by the FDA included lacerations, hemorrhages, penile amputations, and urethral damage.
U.S. Pat. No. 3,072,126 by P. M. Fenton ('126) discloses the use of an axial circular cutting means to apply hemostasis compression to the foreskin as well as to cut the foreskin. The axial compression force applied by the circular cutting means to crush the foreskin invariably stretches and deforms the foreskin. As the circular cutting means is engaged, the foreskin is frequently and inappropriately pushed down over the bell or tube making it difficult to predict the length of foreskin to be removed. Since the same surface is used to cut the foreskin as well as to create the hemostatic crush to the foreskin, it would be difficult to ensure that the foreskin is not inadvertently cut prior to the application of enough compressive pressure to achieve hemostasis leaving the possibility of dangerous bleeding complications. Further, '126 requires use of a bell or tube to shield the glans, necessitating the inherent need for a dorsal slit to be made in the foreskin to facilitate the placement of the foreskin on to the bell or tube.
U.S. Pat. No. 3,473,533 by J. C. Freda ('533) discloses the use of an axial circular cutting means to cut the foreskin after an axially applied force creates a compressive force for hemostasis. The axial compression force to crush the foreskin invariably stretches and deforms the foreskin as the clamping member is applied. As the clamping member is engaged, the foreskin is frequently inappropriately pushed down over the bell or tube making it difficult to predict the length of foreskin to be removed. The incision to the foreskin is made independent of the crush which leaves open the dangerous possibility that an operator can inadvertently administer the cut without having first clamped the foreskin to create hemostasis. Further, '533 requires use of a bell or tube to shield the glans, necessitating the inherent need for a dorsal slit to be made in the foreskin to facilitate the placement of the foreskin on to the bell or tube.
A particular shortcoming shared by the prior art references is that none disclose a means to prevent the possibility of mismatched parts. The possibility of mismatched equipment or the use of a small shield with a large clamp has caused dangerous catastrophic outcomes as regularly reported by the FDA. These injuries are severe and include lacerations and penile amputations.